FDA 510(k) Application Details - K983714

Device Classification Name Image, Illumination, Fiberoptic, For Endoscope

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510(K) Number K983714
Device Name Image, Illumination, Fiberoptic, For Endoscope
Applicant COGENT LIGHT TECHNOLOGIES, INC.
26145 TECHNOLOGY DR.
SANTA CLARITA, CA 91355-1137 US
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Contact DON KNAEPPLE
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Regulation Number 876.1500

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Classification Product Code FFS
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Date Received 10/21/1998
Decision Date 12/23/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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